Low-Dose Aspirin for Preeclampsia Prevention (ASAPP Trial)

Phase 3

Waitlist Available

Led By Line Malha, MD, MS

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Renal disease (proteinuria ≥300mg/day or estimated GFR<90mL/min/1.73 m2)

Autoimmune disease (e.g. systemic lupus erythematous, antiphospholipid syndrome)

Must not have

Contraindication to ASA therapy (including but not limited to allergy and high bleeding risk)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months for each patient (from recruitment until 6 weeks postpartum)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a higher dose of aspirin can help prevent preeclampsia, a dangerous complication of pregnancy.

Who is the study for?

This trial is for pregnant women over 18, under 16 weeks gestation with a history of preeclampsia or risk factors like chronic hypertension, diabetes, renal disease, or autoimmune disorders. It's not for those allergic to aspirin, at high bleeding risk, with major fetal malformations on ultrasound, or planning pregnancy termination.

What is being tested?

The study compares the effectiveness of two low-dose aspirin regimens (81mg vs. 162mg daily) in preventing severe or preterm preeclampsia in high-risk pregnant women. Participants will be randomly assigned to one of the dosages from a single center.

What are the potential side effects?

Aspirin may cause side effects such as gastrointestinal issues (like stomach pain and heartburn), increased bleeding tendency especially during delivery if taken close to labor onset, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have kidney issues with protein in my urine or low kidney function.

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I have an autoimmune disease like lupus.

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I am pregnant, under 16 weeks, and at risk for preeclampsia.

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I have type 1 or type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take ASA due to an allergy or high risk of bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months for each patient (from recruitment until 6 weeks postpartum)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months for each patient (from recruitment until 6 weeks postpartum)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for each patient (from recruitment until 6 weeks postpartum) for reporting.